Z-1283-2024 Class II
Recall Details
- Product Type
- Devices
- Report Date
- March 20, 2024
- Initiation Date
- May 10, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 US
Product Description
LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
Reason for Recall
Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm when an administration set is loaded or coupled while the pump is executing the power-up sequence. May lead to delay in therapy. 2) Alert is not annunciated informing the clinician that the bolus cannot be delivered when the entered bolus dose exceeds the Care Profile Hard Rate Max limit and Rapid Bolus is selected. May lead to over infusion. Both issues were resolved in all fielded product in software version 5.8.0, which was installed in affected units May thru August 2023.
Distribution Pattern
US Nationwide distribution to the states of CA, CO, NJ, WI, UT.
Code Information
UDI-DI 00811505030122 Software versions 5.2.1/5.2.2